9th Qualified Person Forum - European Compliance Academy

Speakers from Authorities and
Public Health Organisations:
Dara Corrigan
Invitation
to the
U.S. Food & Drug Administration (FDA)
Dr Rainer Gnibl
District Government of Upper Bavaria
Mag.pharm. Andreas Kraßnigg
Austrian Agency for Health and Food
Safety (AGES)
Kevin O’Donnell
Irish Health Products Regulatory
Authority (HPRA) (form. IMB)
Edit Szőcs
Hungarian Drug Inspectorate,
National Institute of Pharmacy (NIP)
Maria Wängelin
Swedish Medical Products Agency (MPA)
Speakers from the Industry:
Qualified Person Forum
2014
Vienna, Austria 27 – 28 November 2014
Justin Barry
Midatech Biogune
Richard M. Bonner,
Qualified Person, Chairman of the
Qualified Person Association, form.
with Eli Lilly
Dr Christopher Burgess
EQPA, form. with Glaxo
Dr Dagmar Chase
European CRO Federation
Dr Susanne Ding
Boehringer Ingelheim
Dr Oskar Enzersberger
Baxter
Dr Afshin Hosseiny
Tabriz Consulting
Dr Ulrich Kissel
Roche Pharma
Sue Mann
Sue Mann Consultancy
Ann McGee
McGee Pharma International,
form. Senior Inspector of the Irish
Medicines Board
Geneviève Meeus
Johnson & Johnson
Dr Gabriele Oleschko
Merck KGaA
Frank Raisch
GSK
Dr Rolf Ratke
AbbVie
Stefan Reintgen
Team Connex
Dr Bernd Renger
Immediate Past Chairman of the EQPA
Gillian Renouf
InterMune
Niina Taylor
Pfizer
Philippe Van de Hofstadt
B&C Group
With three Pre-Conference Sessions
on 26 November 2014:
Investigational Medicinal Products
Risk Management in the Supply Chain
OOS and OOT: What’s important for QPs
Welcome
Dear Colleagues,
The European QP Association Forum has
been becoming a major event for European
Qualified Persons.
Speakers from EMA and various national
authorities as well as QPs have been sharing
their view of roles and responsibilities of the Qualified Person.
Hoping to continue the success of the QP Forum, the Advisory
Board of the QP Association has set up the programme at hand for
the 2014 Forum to give you an update about recent developments
and important matters to consider. Representatives from the
authorities as well as QPs and well-known experts will present
latest issues and share their point of view. During the three
pre-conference sessions and the six parallel sessions at the Forum,
various case studies will be presented and discussed to come up
with possible solutions.
Make use of this event by exchanging experiences with your
colleagues and by establishing informal contact and networking.
I would like to invite you to this unique opportunity, and I look
forward to meeting you.
Best regards,
Richard M. Bonner
Chairman of the Qualified Person Association
Background
Over the past few years the role and duties of the Qualified Person
keep increasing in significance and scope. Being the key person in
the quality function of a pharmaceutical company, the QP has to
consider many issues to fulfil the responsibilities and to comply
with the European legislation.
Objective
This Conference is designed by QPs for QPs as an International
Expert Forum with focus on sharing information and experience
and on discussing the critical areas of the QP’s daily work.
Target Group
The Forum is designed for all Qualified Persons and aspiring
Qualified Persons. It also addresses upper management functions
and authority representatives who want to be informed about the
latest development regarding the duties and responsibilities of
Qualified Persons.
Forum Moderator
Dr Christopher Burgess
Important Information!
The presentations of the QP Forum and the Pre-Conference Workshop/ Session will be available for download and your print-out 1
week before the conference. You will also receive a USB memo
stick when you register in Lisbon. Note: there will be no
print-outs available during the conference.
Pre-Conference Sessions
Programme QP Forum
26 November 2014
27 – 28 November 2014
Full Day Pre-Conference Session
Specific Requirements for IMPs
Facilitated by:
IMP Working Group
yy
yy
yy
yy
New legislation impacting IMP QPs
GMP in different clinical phases
The Product Specification File - PSF
Interactive case studies – decision making of IMP QPs
1/2 Day Pre-Conference Session
Risk Management in the Supply Chain
Facilitated by:
Richard M. Bonner / Afshin Hosseiny / Edit Szőcs
yy What the QP needs to know about Supply Chain Risk Management
yy What inspectors expect from the QP
1/2 Day Pre-Conference Session
OOS and OOT: What’s important for QPs
Facilitated by:
Christopher Burgess / Bernd Renger
yy How the QP can rely on the Quality System
yy How to handle IPC results impacting the product’s final quality
The QP in a Global Environment: a positive Picture; Reflections
about Perceptions
yy Perceptions and self-understanding
yy Roles of QPs in a global environment
ÂÂ Rolf Ratke
Current and future Activities of the FDA
yy EU Mutual Reliance Drug Quality Initiative
yy Pharmaceutical Quality for the 21st Century
yy Lifecycle Quality Risk Management
ÂÂ Dara Corrigan
The Role of the QP in Product Recalls
yy EU-GMP Chapter 8
yy Critical Defects and Risk Management
yy Rapid Alert and communication between National Authorities and
the QP
ÂÂ Edit Szőcs
What the QP needs to know about Quality by Design
yy Know your process
yy Risk Management
yy Exceptional Release
ÂÂ Oskar Enzersberger
Law and Order
yy Liability
yy Indemnification
yy Insurance
ÂÂ Frank Raisch
What the QP needs to know about Excipient Quality
yy Transparency and the control of the supply chain
yy Key criteria input
yy Definition of standards
ÂÂ Gabriele Oleschko
The Written Confirmation and the QP: What Inspectors expect
yy Role and responsibilities of the QP
yy Interface with supplier qualification and the Quality System
ÂÂ Rainer Gnibl
Parallel Sessions
Social Event
Working on Case Studies
1) Update on GMP-relevant topics and what QPs are expected
to do
yy Discussion, questions, answers
ÂÂ Bernd Renger and Rainer Gnibl
2) Annex 16 – how to live with it
yy Discussion, questions, answers
ÂÂ Ulrich Kissel and Andreas Kraßnigg
3) QP Scenarios: Would you know what to do?
yy Make decisions based on real-life situations
ÂÂ Sue Mann and Gillian Renouf
On 27 November, you are cordially invited to a social event in Vienna. This
is an excellent opportunity to share your experiences with colleagues
from other companies in a relaxed atmosphere.
Special Offer with Lufthansa – Discounted Travel
4) The Role of the QP in an R&D Environment
yy Challenges with NCEs & Biotech bulk drug substances
yy Comparator sourcing and handling
ÂÂ IMP Working Group
5) How to interpret the PQR
yy What the QP can and should get out of it
ÂÂ Ann McGee and Kevin O’Donnell
6) How to deal with Time Pressure
yy Key tools to plan, organise and set priorities to get the right things
done, every day.
ÂÂ Afshin Hosseiny and Stefan Reintgen
You will be able to attend three of these parallel sessions.
Please choose the ones you like to attend when you register
for the Forum.
As an ECA course or conference attendee,
you will receive up to 20% discounted travel
fares (according to availability). And as
Lufthansa German Airlines offers a comprehensive global route network
linking major cities around the world you will most likely be able to
benefit from these special prices and conditions.
And this is how it works: Once you registered for a course or conference
you will receive a link together with your registration confirmation.
Opening that link will take you to the Mobility Partner Program web-site
where you can enter a code in the “Access to Event Booking” area you will
also receive. This will take you into an online booking platform that will
automatically calculate the discount offered or provide you with an even
better offer if another promotional fare is available.
Q&A Session
During the 2 days of the Forum a bulletin board will be set up where
delegates can post their question cards. The answers will be given by the
expert speakers in this dedicated session and published in the members’
area of the EQPA web-site.
Qualified Person Forum 2014 • Vienna, Austria • 27 – 28 November 2014
Speakers
Speakers from Authorities and Public Health Organisations:
Dara Corrigan, FDA, USA
Assistant Commissioner for Global Regulatory Policy.
Dr Oskar Enzersberger, Baxter AG, Austria
Qualified Person.
Dr Rainer Gnibl, District Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA.
Dr Afshin Hosseiny, Tabriz Consulting, U.K.
Qualified Person and Managing Director.
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food
Safety (AGES), Austria
Head Pharmaceutical Inspections and Member of Annex 16 Drafting
Group.
Dr Ulrich Kissel, Roche Pharma AG, Germany
Qualified Person and Advisory Board member of the Qualified Person
Association.
Kevin O’Donnell, PhD, Irish Health Products Regulatory Authority
(HPRA) (form. IMB), Ireland
Market Compliance Manager.
Edit Szőcs, Hungarian Drug Inspectorate,
National Institute of Pharmacy (NIP), Hungary
Inspector at the Hungarian Drug Inspectorate, National Institute of
Pharmacy (NIP), Advisory Board member of the Qualified Person
Association.
Maria Wängelin, Medical Products Agency (MPA), Sweden
GDP/GMP Inspector.
Speakers from the Industry:
Justin Barry, Midatech Biogune, Spain
Managing Director.
Richard M. Bonner, Chairman of the EQPA
Qualified Person, Chairman of the Qualified Person Association, formerly
with Eli Lilly.
Dr Christopher Burgess, formerly with Glaxo, U.K.
Qualified Person, Advisory Board member of the Qualified Person
Association. Visiting Professor at the Strathclyde Institute of Pharmacy
and Biomedical Sciences (SIPBS).
Dr Dagmar Chase, European CRO Federation (EUCROF)
Vice President EUCROF and Managing Director of Clinrex GmbH.
Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products.
Sue Mann, Sue Mann Consultancy Ltd. U.K.
Qualified Person and QP Assessor working on behalf of the MHRA,
representing the Royal Pharmaceutical Society.
Ann McGee, McGee Pharma International, Ireland
Managing Director and Principal Consultant. Former Senior Inspector of
the Irish Medicines Board and Deputy Chair of PIC/S.
Geneviève Meeus, Janssen Pharmaceutica NV
(part of Johnson & Johnson), Belgium
Director QA Clinical Supply Chain/ IMP QP.
Dr Gabriele Oleschko, Merck KGaA, Germany
Qualified Person and Senior Manager Quality Operations.
Frank Raisch, GSK, Germany
Legal Counsel and Attorney-at-Law.
Dr Rolf Ratke, AbbVie Biotechnology, Germany
Qualified Person and Director Biologics Quality Assurance.
Stefan Reintgen, Team Connex, Germany
Trainer and Coach, formally working for BASF and Celanese
Dr Bernd Renger, EQPA
Immediate Past Chairman of the Qualified Person Association.
Gillian Renouf, InterMune, U.K. and Ireland
Qualified Person and Senior Director Quality.
Niina Taylor, Pfizer, U.K.
Qualified Person and Director Quality Assurance.
Philippe Van de Hofstadt, B&C Group, Belgium
CEO of B&C, a Clinical Research Packaging & Logistics Organisation.
Date Full Day Pre-Conference Session:
Specific Requirements for IMPs
Wednesday, 26 November 2014, 9.30 – 18.00
(Registration and coffee: 9.00 – 9.30)
Date ½ Day Pre-Conference Session:
Risk Management in the Supply Chain
Wednesday, 26 November 2014, 13.00 – 18.00
(Registration, snacks and coffee: 12.30 – 13.00)
Date ½ Day Pre-Conference Session:
OOS and OOT: what’s important for QPs
Wednesday, 26 November 2014, 13.30 – 18.00
(Registration, snacks and coffee: 13.00 – 13.30
Welcome Reception for all participants
Wednesday, 26 November 2014, 18.00 – 19.00
Date QP Forum
Thursday, 27 November 2014, 9.00 – 18.00
(Registration: Wednesday, 26 November 18.00 – 19.00 and
Thursday 27 November 2014, 8.00 – 9.00)
Friday, 28 November 2014, 8.30 – 14.30
Venue
Austria Trend Hotel Park Royal Palace Vienna
Schlossallee 8
1140 Vienna
Austria
Tel.: +43 1 8911 0
Fax:+43 1 8911 9050
Fees for QP Forum
QP Association Members € 1.590,- per delegate plus VAT.
EU GMP Inspectorates € 895,- per delegate plus VAT.
Non-QP Association Members € 1.790,- per delegate plus VAT.
The conference fee is payable in advance after receipt of invoice and
includes electronic conference documentation, welcome reception,
dinner on the first day, lunch on both days and all refreshments. VAT is
reclaimable.
Fees for Full Day Pre-Conference Session:
Specific Requirements for IMPs
€ 890,- per delegate plus VAT.
The fee is payable in advance after receipt of invoice and includes
electronic conference documentation, welcome reception, lunch and all
refreshments. VAT is reclaimable.
Fees for ½ Day Pre-Conference Session:
Risk Management in the Supply Chain
€ 590,- per delegate plus VAT.
The fee is payable in advance after receipt of invoice and includes
electronic conference documentation, welcome reception and all
refreshments. VAT is reclaimable.
Fees for ½ Day Pre-Conference Session:
OOS and OOT: What’s important for QPs
€ 590,- per delegate plus VAT.
The fee is payable in advance after receipt of invoice and includes
electronic conference documentation, welcome reception and all
refreshments. VAT is reclaimable.
Saving opportunities:
Book both the QP Forum and a Pre-Conference Session:
Delegates who attend the QP Forum and a Pre-Conference Session
will get a discount of 200€ on the QP Forum.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the
conference hotel. You will receive a room reservation link when you have
registered for the event. Please use this link for your room reservation or
be sure to mention QP Association to receive the specially negotiated
rate (single room 125,- Euros per night incl. breakfast) for the duration of
your stay. Reservation should be made directly with the hotel not later
than 5 October 2014. Early reservation is recommended.
Registration
Via the attached reservation form, by e-mail to [email protected] or
by fax to +49 6221 / 84 44 34 . Or you register online at
www.qp-forum.org.
Conference Language
The official conference language will be English.
Organisation / Contact
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34
E-mail: [email protected]
www.concept-heidelberg.de
For questions regarding content:
Mr Wolfgang Schmitt (Operations Director) at +49-62 21 / 84 44 39,
or per e-mail at [email protected].
For questions regarding reservation, hotel, organisation etc:
Ms Marion Grimm (Organisation Manager) at +49 (0) 62 21 / 84 44 18,
or per e-mail at [email protected].
Country
Important: This is a binding registration and above fees
are due in case of cancellation or non-appearance. If you
cannot take part, you have to inform us in writing. The
cancellation fee will then be calculated according to the
point of time at which we receive your message. In case
you do not appear at the event without having informed
us, you will have to pay the full registration fee even if you
have not made the payment yet. You are not entitled to
participate in the conference until we have received your
payment (receipt of payment will not be confirmed)!
E-mail ( Please fill in)
Phone / Fax
City
Street / P.O. Box
P.O Number (if applicable)
Zip Code
Important: Please indicate your company’s VAT ID Number
D-69007 Heidelberg
CompanyDepartment
CONCEPT HEIDELBERG
Postfach 10 17 64
Fax 06221/84 44 34
Title, first name, surname
Terms of payment: Payable without deductions within 10
days after receipt of invoice.
About the European QP Association
The European Qualified Person (QP) Association was
founded on 7 July 2006 by the European Compliance
Academy’s (ECA) Advisory Board Members. With this
unique association the ECA wants to provide QPs in Europe
with a platform allowing them to exchange their experience, discuss the latest regulatory requirements, to identify
and address difficulties and challenges and to support a
harmonised European approach.
*
Ms
*
Mr
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Optional Pre-Conference Session, Vienna, Austria, 26 November 2014
Please choose one of the following:
*
Full Day Session “Investigational Medicinal Products”
*
1/2 Day Session “Risk Management in the Supply Chain”
*
1/2 Day Session “OOS and OOT: What’s important for QPs ”
*
Qualified Person Forum 2014, Vienna, Austria, 27-28 November 2014
Please choose three of the six parallel sessions:
*
Session 1: Update on GMP-relevant topics and what QPs are expected to do
*
Session 2: Annex 16 – how to live with it
*
Session 3: QP Scenarios: Would you know what to do?
*
Session 4: The Role of the QP in an R&D Environment
*
Session 5: How to interpret the PQR
*
Session 6: How to deal with Time Pressure
Reservation Form (Please complete in full)
If the bill-to-address deviates from the specification to the
right, please fill out here:
General Terms of Business
If you cannot attend the conference you have two options:
1. We are happy to welcome a substitute colleague at any
time.
2. If you have to cancel entirely, we must charge the
following processing fees: Cancellation
• until 2 weeks prior to the conference 10 % of the
registration fee.
• until 1 week prior to the conference 50 % of the
registration fee.
• within 1 week prior to the conference 100 % of the
registration fee.
CONCEPT HEIDELBERG reserves the right to change the
materials, instructors, or speakers without notice or to
cancel an event. If the event must be cancelled, registrants
will be notified as soon as possible and will receive a full
refund of fees paid.
CONCEPT HEIDELBERG will not be responsible for discount
airfare penalties or other costs incurred due to a cancellation.
More information about the QP Association and a
membership application form are available at www.
qp-association.eu.
About CONCEPT HEIDELBERG
Founded in 1978, CONCEPT HEIDELBERG is the leading
organiser of seminars on pharmaceutical production,
quality control, quality assurance and GMP in Europe. This
year more than 240 events will be organised by CONCEPT
HEIDELBERG. The European QP Association has entrusted
CONCEPT HEIDELBERG with the organisation of its events.
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